Company ยท US
Visby Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 3 |
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | 1 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 1 |
| SEA | Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users | 1 |
| SIA | Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 2026 | K253971 | Visby Medical Flu and COVID-19 Test Visby Medical, Inc. | SIA |
| Oct 1, 2025 | K251501 | Visby Medical Men's Sexual Health Test Visby Medical, Inc. | QEP |
| Mar 28, 2025 | DEN240020 | Visby Medical Women's Sexual Health Test Visby Medical, Inc. | SEA |
| Feb 19, 2025 | K242526 | Visby Medical Respiratory Health Test Visby Medical, Inc. | QOF |
| Mar 7, 2023 | K220407 | Visby Medical Sexual Health Test Visby Medical | QEP |
| Aug 26, 2021 | K200748 | Visby Medical Sexual Health Visby Medical | QEP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2020 | VISBY MEDICAL INC visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administ Terminated |
QJR | None listed |